BEUDAMED
    FDA Adverse Event Other Summary report: N

    KARL STORZ

    MDR report key: 3118643 · Received April 5, 2013

    Report

    Report Number
    9610617-2013-00014
    Event Type
    Other
    Date Received
    April 5, 2013
    Manufacturer
    KARL STORZ GMBH & CO. KG
    Product Code
    FCL
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    OUR SALES REPRESENTATIVE WAS PRESENT DURING PROCEDURE AND REPORTED THAT HE SAW WHAT APPEARED TO BE AN INJURY TO THE BLADDER AFTER SURGEON ACTIVATED THE ELECTRODE. AFTER MULTIPLE ATTEMPTS TO CONTACT THE FACILITY, WE WERE UNABLE TO GET CONFIRMATION THAT THE PATIENT ACTUALLY SUSTAINED NO INJURY. THE SAME ELECTRODE WAS USED TO COMPLETE THE PROCEDURE AND WAS DISPOSED OF AFTER PROCEDURE WAS COMPLETED.

    Description of Event or Problem · 1

    IMP (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    141843 KARL STORZ BIPOLAR CUTTING LOOP FCL KARL STORZ GMBH & CO. KG

    Patients

    Seq Age Sex Outcome Treatment
    1